Cost effectiveness of follow-up with diffusion-weighted MRI versus surgical follow-up after cholesteatoma treatment.

Cost effectiveness of follow-up with diffusion-weighted MRI versus surgical follow-up after cholesteatoma treatment. - Cost effectiveness of MRI diffusion in cholesteatoma follow-up

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON47835

Enrollment

153

Registered

2017-03-20

Start date

2017-05-30

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cholesteatoma middle ear sac of skin

Interventions

INTERVENTION Annual diffusion-weighted MRI during 3 consecutive years, starting 1 year after primary surgery. STANDARD INTERVENTION TO BE COMPARED TO Second look surgery 1 year after primary surge

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria RCT * 18 years of age or older. * patients who underwent a surgical procedure (canal wall up tympanoplasty) for eradication of primary or recurrent acquired cholesteatoma * primary surgery at a maximum of 11 months prior to the start of the study. * patients with normal to mild conductive hearing loss, defined as: mean air-bone gap of less than or equal to (*) 20dB on pure tone audiometry at frequencies of 0.5, 1 and 2 kHz . * capable and willing to participate in a follow-up study of three years

Exclusion criteria

Exclusion criteria: * patients who underwent a canal wall down tympanoplasty procedure as last ear surgical procedure (patients with a canal wall down procedure in the last 10 months will be requested to participate in the cholesteatoma observational study, which is an anonymous follow-up study of usual care in post-cholesteatoma surgery patients without randomization);* patients with a moderate to severe average air-bone gap of more than (>) 20 dB (patients eligible for a chain reconstruction will be requested to participate in the cholesteatoma observational study);* patients not capable to undergo a MRI (claustrophobic, metal parts or implants in the body etc.)

Design outcomes

Primary

Measure	Time frame
OUTCOME MEASURES 1. The degree of hearing loss after 3 thee years of follow-up	—

Secondary

Measure	Time frame
2. The costs of three years follow-up 3. The number of 2nd look surgeries without cholesteatoma present (unnecessary surgical procedures)and the number of residual and recurrent cholesteatoma, health related quality of life and number of complications	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)